REMASTer: REcurrent Brain Metastases After SRS Trial
Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.
• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Patients with radiographically proven (by gadolinium-enhanced \[Gd-\] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer.
• Patients with a targetable, bidimensionally-measurable, intracranial lesion that is radiographically recurrent after previous treatment with SRS +/- surgery (craniotomy or LITT). To classify a lesion as radiographically progressive, the lesion must demonstrate a ≥ 25% increase in size following treatment based on the Neuro-Oncology Criteria of Tumor Response for CNS Tumors. To be targetable for this study, the lesion should be coverable through a planned single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm. An intra-operative decision to utilize two trajectories is acceptable and patient may remain on study.
• Patient must be at least 3 months post initial SRS treatment of the target lesion
• Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon.
• Frozen pathology diagnosis must be attainable.
• Patient must be symptomatically stable for a minimum of 3 days prior to the procedure date on a on a max total daily steroid dose equivalent to 4mg of Dexamethasone.
• ≥18 years of age
• KPS ≥70
• Patient is able and willing to complete study requirements
⁃ Patients with adequate hematologic parameters (all tests to be performed within \<4 weeks of biopsy):
∙ ANC ≥ 1.5 X 109/L
‣ Platelet count ≥ 100 x 109/L
⁃ Blood chemistry laboratory value for serum creatinine \< 1.5 x ULN (test to be performed within \<4 weeks of biopsy)
⁃ Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)
⁃ All patients of reproductive potential must agree to use an effective method of contraception during the study
⁃ Patients must be accessible for follow-up